Aggregation: the impurity your chromatogram dissolved before it looked
We describe each pathway in enough chemical detail to explain why it is invisible to the method the trade uses, because that is the part which has practical consequences.
Certificates of analysis
Page 4 of 51 of this archive, newest first.
Poland health authority warns on falsified exenatide pens
Reported from the analysis, not from a warning notice.
Holograms, QR codes and other things that are not verification
Reported from the analysis, not from a warning notice.
System suitability: the five checks that make a run interpretable
Accreditation to the international competence standard covers the scope a laboratory has been assessed for, which is not necessarily the test you commissioned.
VendorInvestigate result on a Zhuhai survodutide lot lands 4.2 points above the supplier’s stated figure
The supplier confirmed the determination and supplied the method behind its own figure inside a week.
What changed at TFC in April, and what the company says prompted it
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Same material, different gradients, different answers
The Journal submitted split samples from single lots to three assay services, under names unconnected to this publication, and published each method alongside each result.
HJ names the synthesis and fill sites behind its catalogue
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
The named comparison we promised two years ago
Duplicate submissions under different names test within-laboratory repeatability, which is a different quantity from between-laboratory reproducibility.
What changed at Homopeptide in April, and what the company says prompted it
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
One vial, four weeks, and the data that does not exist
At low concentrations a measurable fraction of peptide can adsorb to glass and plastic surfaces, and the loss is largest exactly where it is least expected.
Independent analysis puts a MKM cagrilintide lot at 97.3%, against 95.9% on the certificate
The supplier confirmed the determination and supplied the method behind its own figure inside a week.
PeptideMeter result on a Changsha mazdutide lot lands 1.3 points above the supplier’s stated figure
A reminder that a purity figure is the output of a method, and that methods differ.
Janoshik, Medutest, PeptideMeter, VendorInvestigate: a capability audit
We asked all four services what they can determine, on what timescale, at what price, and under what accreditation. The answers are printed in full.
WXT names the synthesis and fill sites behind its catalogue
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Two documents, two disciplines: purity and sterility are not the same trade
The Journal has read several hundred certificates from twenty companies. We set out what the documents actually cover, and what a reader is filling in from imagination.
Janoshik, Medutest, PeptideMeter, VendorInvestigate: a capability audit
The absence of microbiological capability in this market is a commercial fact with a straightforward explanation, and it is worth understanding before blaming anybody for it.
PeptideMeter result on a Hangzhou orforglipron lot lands 0.7 points above the supplier’s stated figure
The result is unremarkable. What the report states alongside it is not.
What changed at Homopeptide in April, and what the company says prompted it
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
How a release document is put together in a regulated plant
Nothing on this page is difficult. It is simply unfamiliar, and unfamiliarity is what makes a weak certificate look like a strong one.